Embedding AI And Critical IRB Operations Data To Drive Intelligent Study Design

This presentation offers a clear roadmap for navigating the evolving complexities of the industry. Modern clinical trial design is being transformed by a rich array of data sources, from digitized protocols and literature to real-world insights. This discussion centers on how researchers can effectively evaluate and integrate these diverse data streams to create studies that are not only operationally efficient but also more inclusive and scientifically robust.

A primary focus is the role of AI in driving intelligent data synthesis while balancing innovation with practical feasibility. By leveraging analytical models and AI techniques, pharma leaders can transform complex inputs into meaningful insights, ultimately maximizing the potential of their research programs. Furthermore, exploring distinct vantage points—such as IRB operations data—can provide critical foresight, helping to preempt study hurdles and minimize the need for costly amendments.

Speakers: Dr. Nimita Limaye Research VP, Life Sciences R&D Strategy and Technology, IDC Dr. Nimita Limaye, Research VP, IDC, provides strategic advisory and market analysis on key topics related to Life Sciences R&D Strategy and Technology, and is IDC’s primary life sciences AI analyst. An executive business leader with over three decades of life sciences leadership experience, spanning pharma, CRO, and tech consulting, she has led business strategy and managed large global operations.

An extremely well networked thought leader, she has been ranked amongst the top 50 analysts in the AR100 Market Amplifiers Power 100 list in Q4 2025. She was the recipient of the 2024 DIA Global Inspire Award and has served as the past chair of the SCDM board. She is the current chair of the DIA Global Medical Writing community,

Based in Boston, Nimita is a sought-after speaker and has delivered multiple keynote talks, presented in multiple global forums, and has authored over 100 thought leadership papers. She has served as an invited mentor to digital health-tech start-ups, and is passionate about how data, tech, and analytics are transforming life sciences and healthcare.

Ian Bailey Managing Director of AI & Data Science Analytics, Advarra Ian Bailey is the Managing Director of AI & Data Science Analytics at Advarra, where he leads strategy and commercialization for AI and data solutions that enhance study design and clinical operations. He has extensive experience in clinical research technology and more than fifteen years in enterprise data and software, helping organizations bridge the gap between innovation and execution. His work focuses on transforming diverse clinical and operational data sources into actionable intelligence that drives more efficient, inclusive, and scientifically sound trials.